Regulatory Strategy

BrainHealing Inc. in collaboration with First Institute of All medicines (www.firstallmed.org) and Tesla BioHealing Inc. (www.teslabiohealing.com), is developing non-invasive photonic therapeutic technologies intended to support neurological recovery in several major unmet medical conditions, including chronic stroke, traumatic brain injury (TBI), Parkinson’s disease, and Alzheimer’s disease.

To responsibly advance clinical research in these areas, BrainHealing has adopted a phased regulatory strategy aligned with U.S. Food and Drug Administration (FDA) clinical investigation requirements for medical devices.

This strategy prioritizes patient safety, institutional oversight, and progressive clinical validation before seeking regulatory authorization.

The initial clinical investigations conducted for these neurological conditions were designed as pilot studies under the FDA framework for Nonsignificant Risk (NSR) medical device investigations.

Nonsignificant Risk (NSR) Device Clinical Investigation Framework

Under the FDA’s device investigation regulations (21 CFR Part 812), certain medical device studies may qualify as Nonsignificant Risk (NSR) investigations.

A Nonsignificant Risk device is defined as a device that does not pose a significant risk to the health, safety, or welfare of human subjects.

Examples provided in FDA guidance include:

• Daily-wear contact lenses
• Lens cleaning solutions
• Ultrasonic dental scalers
• Foley catheters

For studies involving NSR devices, the FDA allows a streamlined clinical research pathway.

Key Elements of NSR Device Studies

According to FDA regulations:

• IRB approval is required prior to study initiation.

• Sponsors are not required to submit an IDE application to the
   FDA.

• Clinical investigation submissions are made directly to the
   Institutional Review Board (IRB) of each participating
    institution.

• Sponsors must present justification explaining why the device
   does not pose a significant risk to study participants.

• If the IRB determines the device is significant risk (SR) instead
   of NSR, the sponsor must notify the FDA within five working
   days.

• Once the IRB concurs that the study involves a nonsignificant
   risk device and approves the protocol, the investigation is
   considered to have an approved Investigational Device
   Exemption (IDE) under FDA regulations.

This framework allows early-stage clinical research to proceed efficiently while maintaining full ethical and regulatory oversight

Application of the NSR Pathway to BrainHealing Pilot Studies

The initial pilot clinical investigations conducted for BrainHealing’s neurological programs were designed under this Nonsignificant Risk device study pathway.

These studies were performed with:

• Institutional Review Board (IRB) oversight

• Human subject protection compliance

• Defined clinical protocols

• Safety monitoring

The NSR pathway allowed early feasibility studies to evaluate safety signals and preliminary clinical outcomes in neurological disorders where new therapeutic options are urgently needed.

Clinical Programs Conducted Under NSR Pilot Studies

The following neurological programs have completed pilot studies under this regulatory framework.

Chronic stroke remains one of the leading causes of long-term disability worldwide.

BrainHealing pilot studies investigated whether photonic-based therapy may influence neurological function in individuals living with chronic stroke. Early studies evaluated biomarkers including:

• Quantitative EEG (qEEG)
• Blood circulation parameters
• Functional neurological assessments
• Regenerative biological markers

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The pilot studies generated preliminary signals supporting further clinical investigation.

Traumatic Brain Injury (TBI)

Traumatic brain injury is a major cause of long-term neurological impairment.

Early Clinical Investigations Evaluated:

• EEG markers of brain network activity
• Biomarkers of neuronal injury
• Cognitive and neurological functional measures

These pilot studies aimed to determine whether non-invasive photonic interventions could influence neurophysiological recovery processes.

Parkinson’s Disease

Parkinson’s disease is characterized by progressive motor and non-motor neurological decline.

Pilot clinical investigations explored potential changes in:

• EEG biomarkers associated with brain network activity
• Microcirculation and blood characteristics
• Patient-reported symptom outcomes

The purpose of these studies was to assess feasibility and identify signals that may justify larger controlled clinical trials.

Alzheimer’s Disease

Alzheimer’s disease is a leading cause of dementia globally, with limited disease-modifying treatments currently available.

Pilot studies conducted under IRB oversight evaluated:

• Quantitative EEG changes associated with cognitive function

• Caregiver-reported cognitive and behavioral outcomes

• Microcirculatory and systemic physiological markers

These studies generated early data supporting continued investigation of the therapy’s potential neurological effects.

Next Phase Of Development

The pilot NSR studies were designed as early feasibility investigations to evaluate safety and preliminary biological and clinical signals.

Based on the results obtained, BrainHealing’s regulatory strategy for the next stage includes:

• Expanded multi-center clinical trials
• Larger patient populations
• Controlled study designs
• Continued IRB oversight and regulatory compliance

Future regulatory interactions may include:

• Pre-Submission meetings with the FDA
• IDE submissions if required for later-stage trials
• 510(k), De Novo, or other regulatory pathways depending on device classification

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Commitment to Regulatory Compliance and Patient Safety

BrainHealing is committed to conducting clinical research in accordance with:

• FDA medical device regulations
• Institutional Review Board oversight
• Good Clinical Practice (GCP) principles
• Ethical standards for human subject protection

The NSR clinical studies represent the first step in a long-term development program focused on generating rigorous clinical evidence to support innovative neurological therapies.

Development Framework

The platform follows a structured development pathway:

1. Scientific rationale
2. Pilot clinical evaluation
3. Expanded controlled trials
4. Regulatory review
5. Potential clinical adoption

Strategic collaboration with clinical investigators and regulatory experts is expected to play an important role in advancing these programs.

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Recent work from our group further supports the translational relevance of biophoton therapy in chronic stroke. Multimodal findings have shown improvements in cerebral hemodynamics, EEG activity, cognitive function, motor performance, and hemorheology in chronic stroke patients treated with biophoton-based interventions.

Disclaimer: BrainHealing.com provides informational content regarding investigational neurological treatment programs and related scientific development activities. The information presented on this website is intended for investors, researchers, healthcare professionals, and potential strategic partners.

The investigational programs described on this website are under evaluation and are not offered for commercial sale. Statements on this website should not be interpreted as claims of regulatory approval, medical efficacy, or therapeutic effectiveness unless explicitly stated.

Nothing on this website constitutes medical advice. Individuals should consult qualified healthcare professionals regarding medical conditions or treatment decisions.